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Citation
Clarke, William (2020). Peritransplant Deoxyspergualin in Islet Transplantation in Type 1 Diabetes and Extended Follow Up after Islet Transplantation in Type 1 Diabetes (CIT-03/08) (Version 1) [Dataset] NIDDK Central Repository. https://doi.org/10.58020/djpt-4d91
Data Availability Statement
Data from Peritransplant Deoxyspergualin in Islet Transplantation in Type 1 Diabetes and Extended Follow Up after Islet Transplantation in Type 1 Diabetes (CIT-03/08) [(Version 1) https://doi.org/10.58020/djpt-4d91] reported here are available for request at the NIDDK Central Repository (NIDDK-CR) website, Resources for Research (R4R), https://repository.niddk.nih.gov/.
Acknowledgement Statement
The CIT-03/08 study was conducted by the study investigators and supported by the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). The resources from the CIT-03/08 (https://doi.org/10.58020/djpt-4d91) study reported here were supplied by NIDDK Central Repository (NIDDK-CR) and are available for request at https://repository.niddk.nih.gov. This manuscript was not prepared under the auspices of the CIT-03/08 study and does not necessarily reflect the opinions or views of the CIT-03/08 study, NIDDK-CR, or NIDDK.
Data Package Version
Version 1 (Updated on: Dec 16, 2020)
Resource Availability
  • Data Available for Request
  • Specimens Available for Request
Publications
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General Description

The CIT consortium conducted a total of 9 studies across North America (CIT02 through CIT08) and the Nordic region (CIT01). CIT08 was a long-term follow-up study for interested participants at the North American sites. The target population was individuals with type 1 diabetes, normal kidney function, and intractable hypoglycemia. All studies treated participants with up to 3 separate infusions of islets. The focus of CIT03 was to evaluate the investigational agent, deoxyspergualin. Subjects in CIT03 received rabbit anti-thymocyte globulin (ATG; basiliximab instead of ATG for the 2nd and 3rd transplants, if applicable), deoxyspergualin, etanercept, sirolimus, and low-dose tacrolimus in an open-label fashion.

Objectives

CIT-03: The primary objective of this protocol is to assess the safety and efficacy of an immunosuppressive regimen consisting of ATG (1st transplant only), basiliximab (subsequent transplants only), etanercept, DSG, sirolimus, and low-dose tacrolimus on post-transplant islet function in subjects with T1D.

CIT-08: The primary objective is to provide extended follow-up for safety and efficacy and to support continued islet graft function to participants previously enrolled in CIT02, CIT03, CIT04, CIT05, CIT06, or CIT07.

Outcome Measure

The primary outcome measure was the proportion of participants with insulin independence at 75 days following the first transplant infusion. Secondary outcome measures included reduction in insulin requirements, mean amplitude of glycemic excursions, HbA1c levels, incidence of immune sensitization (defined by detected anti-HLA antibodies not present prior to transplantation), and quality of life.

Eligibility Criteria

Individuals who met the following criteria were eligible for enrollment:

  • Clinical history compatible with type 1 diabetes with onset at less than 40 years of age, insulin dependence for at least 5 years at study entry, and a sum of age and insulin dependent diabetes duration of at least 28
  • Absent stimulated C-peptide (less than 0.3 ng/mL) 60 and 90 minutes post-mixed-meal tolerance test
  • Involvement of intensive diabetes management, defined as: (1) Self-monitoring of glucose values no less than a mean of three times each day averaged over each week; (2) Administration of three or more insulin injections each day or insulin pump therapy; (3) Under the direction of an endocrinologist, diabetologist, or diabetes specialist with at least three evaluations during the 12 months prior to study enrollment
  • At least one episode of severe hypoglycemia in the 12 months prior to study enrollment
  • Reduced awareness of hypoglycemia.

Exclusion criteria are documented in the study protocol.

Outcome

This study has been concluded, but results have not yet been published.

Research Area

Diabetes

Study Type

Interventional

Study Sites

3

Study Start Date

2006-10

Study End Date

2013-11

Condition

Type 1 Diabetes Mellitus

Keywords

Sirolimus, Immunosuppresive Medication Regimen, Deoxyspergualin, Diabetes Mellitus, Type1, Normal Kidney Function, Etanercept, Tacrolimus, Intractable Hypoglycemia, Islet Cell Transplant, Basiliximab, Rabbit Anti-Thymocyte Globulin

NIDDK Division

Division of Diabetes, Endocrinology, and Metabolic Diseases

14
Participants

Target Population
Adults, Transplant Patients

Sex

Bar chart with 2 data series.
The chart has 1 X axis displaying categories.
The chart has 1 Y axis displaying values. Data ranges from 4 to 10.
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Public Documents Table
Document Name
Description
Document Type
File Format
Compliance
Download
Data Dictionary - Albumin Dataset
Albumin Dataset Data Dictionary used as a collection of metadata - defines the dataset's variable contentsCodebook/Data DictionaryXLSX
Data Dictionary - Albumin Creatinine GFR Components Dataset
Albumin Creatinine GFR Components Dataset Data Dictionary used as a collection of metadata - defines the dataset's variable contentsCodebook/Data DictionaryXLSX
Data Dictionary - AlkPhos Dataset
AlkPhos Dataset Data Dictionary used as a collection of metadata - defines the dataset's variable contentsCodebook/Data DictionaryXLSX
Data Dictionary - ALT Dataset
ALT Dataset Data Dictionary used as a collection of metadata - defines the dataset's variable contentsCodebook/Data DictionaryXLSX
Data Dictionary - AST Dataset
AST Dataset Data Dictionary used as a collection of metadata - defines the dataset's variable contentsCodebook/Data DictionaryXLSX
Data Dictionary - Atherogenic Dataset
Atherogenic Dataset Data Dictionary used as a collection of metadata - defines the dataset's variable contentsCodebook/Data DictionaryXLSX
Data Dictionary - Autoantibodies Dataset
Autoantibodies Dataset Data Dictionary used as a collection of metadata - defines the dataset's variable contentsCodebook/Data DictionaryXLSX
Data Dictionary - Beta Score Dataset
Beta Score Dataset Data Dictionary used as a collection of metadata - defines the dataset's variable contentsCodebook/Data DictionaryXLSX
Data Dictionary - Bilirubin Dataset
Bilirubin Dataset Data Dictionary used as a collection of metadata - defines the dataset's variable contentsCodebook/Data DictionaryXLSX
Data Dictionary - Blood sugar and Hypoglycemic Events Dataset
Blood Sugar Record and Hypoglycemic Events Dataset Data Dictionary used as a collection of metadata - defines the dataset's variable contentsCodebook/Data DictionaryXLSX
Data Dictionary - Blood Type and HLA Dataset
Blood Type and HLA Dataset Data Dictionary used as a collection of metadata - defines the dataset's variable contentsCodebook/Data DictionaryXLSX
Data Dictionary - BUN Dataset
BUN Dataset Data Dictionary used as a collection of metadata - defines the dataset's variable contentsCodebook/Data DictionaryXLSX
Data Dictionary - Calcium Dataset
Calcium Dataset Data Dictionary used as a collection of metadata - defines the dataset's variable contentsCodebook/Data DictionaryXLSX
Data Dictionary - Central HDL Dataset
Local HDL Dataset Data Dictionary used as a collection of metadata - defines the dataset's variable contentsCodebook/Data DictionaryXLSX
Data Dictionary - Central LDL Dataset
Local LDL Dataset Data Dictionary used as a collection of metadata - defines the dataset's variable contentsCodebook/Data DictionaryXLSX
Data Dictionary - Central Total Cholesterol Dataset
Local Total Cholesterol Dataset Data Dictionary used as a collection of metadata - defines the dataset's variable contentsCodebook/Data DictionaryXLSX
Data Dictionary - Central Triglycerides Dataset
Local Triglycerides Dataset Data Dictionary used as a collection of metadata - defines the dataset's variable contentsCodebook/Data DictionaryXLSX
Data Dictionary - CGMS Dataset
CGMS Dataset Data Dictionary used as a collection of metadata - defines the dataset's variable contentsCodebook/Data DictionaryXLSX
Data Dictionary - Chloride Dataset
Chloride Dataset Data Dictionary used as a collection of metadata - defines the dataset's variable contentsCodebook/Data DictionaryXLSX
Data Dictionary - CIMT Dataset
CIMT Dataset Data Dictionary used as a collection of metadata - defines the dataset's variable contentsCodebook/Data DictionaryXLSX
Data Dictionary - Clarke Score Dataset
Clarke Score Dataset Data Dictionary used as a collection of metadata - defines the dataset's variable contentsCodebook/Data DictionaryXLSX
Data Dictionary - CO2 Dataset
CO2 Dataset Data Dictionary used as a collection of metadata - defines the dataset's variable contentsCodebook/Data DictionaryXLSX
Data Dictionary - Cpeptide/Glucose/Creatinine Dataset
Cpeptide/Glucose/Creatinine Dataset Data Dictionary used as a collection of metadata - defines the dataset's variable contentsCodebook/Data DictionaryXLSX
Data Dictionary - DDS Dataset
DDS Dataset Data Dictionary used as a collection of metadata - defines the dataset's variable contentsCodebook/Data DictionaryXLSX
Data Dictionary - Demographics Dataset
Demographics Dataset Data Dictionary used as a collection of metadata - defines the dataset's variable contentsCodebook/Data DictionaryXLSX
Data Dictionary - Diastolic Blood Pressure Dataset
Diastolic Blood Pressure Dataset Data Dictionary used as a collection of metadata - defines the dataset's variable contentsCodebook/Data DictionaryXLSX
Data Dictionary - Drug Dose Dataset
Drug Dose Dataset Data Dictionary used as a collection of metadata - defines the dataset's variable contentsCodebook/Data DictionaryXLSX
Data Dictionary - EQ5D Dataset
EQ5D Dataset Data Dictionary used as a collection of metadata - defines the dataset's variable contentsCodebook/Data DictionaryXLSX
Data Dictionary - FSIGT AIRglu Dataset
FSIGT AIRglu Dataset Data Dictionary used as a collection of metadata - defines the dataset's variable contentsCodebook/Data DictionaryXLSX
Data Dictionary - FSIGT Raw Dataset
FSIGT Raw Dataset Data Dictionary used as a collection of metadata - defines the dataset's variable contentsCodebook/Data DictionaryXLSX
Data Dictionary - GammaGT Dataset
GammaGT Dataset Data Dictionary used as a collection of metadata - defines the dataset's variable contentsCodebook/Data DictionaryXLSX
Data Dictionary - General Assessment Dataset
General Assessment Dataset Data Dictionary used as a collection of metadata - defines the dataset's variable contentsCodebook/Data DictionaryXLSX
Data Dictionary - GFR Dataset
GFR Dataset Data Dictionary used as a collection of metadata - defines the dataset's variable contentsCodebook/Data DictionaryXLSX
Data Dictionary - HbA1c Dataset
HbA1c Dataset Data Dictionary used as a collection of metadata - defines the dataset's variable contentsCodebook/Data DictionaryXLSX
Data Dictionary - Hematocrit Dataset
Hematocrit Dataset Data Dictionary used as a collection of metadata - defines the dataset's variable contentsCodebook/Data DictionaryXLSX
Data Dictionary - Hemoglobin Dataset
Hemoglobin Dataset Data Dictionary used as a collection of metadata - defines the dataset's variable contentsCodebook/Data DictionaryXLSX
Data Dictionary - HFS Dataset
HFS Dataset Data Dictionary used as a collection of metadata - defines the dataset's variable contentsCodebook/Data DictionaryXLSX
Data Dictionary - Hypo Recall Dataset
Hypo Recall Dataset Data Dictionary used as a collection of metadata - defines the dataset's variable contentsCodebook/Data DictionaryXLSX
Data Dictionary - Full Hypo Score Dataset
Full Hypo Score Dataset Data Dictionary used as a collection of metadata - defines the dataset's variable contentsCodebook/Data DictionaryXLSX
Data Dictionary - IEQ Infused Dataset
IEQ Infused Dataset Data Dictionary used as a collection of metadata - defines the dataset's variable contentsCodebook/Data DictionaryXLSX
Data Dictionary - Insulin Dataset
Insulin Dataset Data Dictionary used as a collection of metadata - defines the dataset's variable contentsCodebook/Data DictionaryXLSX
Data Dictionary - LI Score Dataset
LI Score Dataset Data Dictionary used as a collection of metadata - defines the dataset's variable contentsCodebook/Data DictionaryXLSX
Data Dictionary - Local HDL Dataset
Local HDL Dataset Data Dictionary used as a collection of metadata - defines the dataset's variable contentsCodebook/Data DictionaryXLSX
Data Dictionary - Local Serum Creatinine Dataset
Local Serum Creatinine Dataset Data Dictionary used as a collection of metadata - defines the dataset's variable contentsCodebook/Data DictionaryXLSX
Data Dictionary - Local Total Cholesterol Dataset
Local Total Cholesterol Dataset Data Dictionary used as a collection of metadata - defines the dataset's variable contentsCodebook/Data DictionaryXLSX
Data Dictionary - Local Triglycerides Dataset
Local Triglycerides Dataset Data Dictionary used as a collection of metadata - defines the dataset's variable contentsCodebook/Data DictionaryXLSX
Data Dictionary - Loca LDL Dataset
Local LDL Dataset Data Dictionary used as a collection of metadata - defines the dataset's variable contentsCodebook/Data DictionaryXLSX
Data Dictionary - Lymphocytes Dataset
Lymphocyte Dataset Data Dictionary used as a collection of metadata - defines the dataset's variable contentsCodebook/Data DictionaryXLSX
Data Dictionary - MAGE Score Dataset
MAGE Score Dataset Data Dictionary used as a collection of metadata - defines the dataset's variable contentsCodebook/Data DictionaryXLSX
Data Dictionary - Magnesium Dataset
Magnesium Dataset Data Dictionary used as a collection of metadata - defines the dataset's variable contentsCodebook/Data DictionaryXLSX
Data Dictionary - Manufacturing Other Data Dataset
Manufacturing Other Data Dataset Data Dictionary used as a collection of metadata - defines the dataset's variable contentsCodebook/Data DictionaryXLSX
Data Dictionary - Manufacturing Unused Lots Dataset
Manufacturing Unused Lots Dataset Data Dictionary used as a collection of metadata - defines the dataset's variable contentsCodebook/Data DictionaryXLSX
Data Dictionary - Mean Insulin per kg Dataset
Mean Insulin per kg Dataset Data Dictionary used as a collection of metadata - defines the dataset's variable contentsCodebook/Data DictionaryXLSX
Data Dictionary - Medical and Diabetes History Dataset
Medical and Diabetes History Dataset Data Dictionary used as a collection of metadata - defines the dataset's variable contentsCodebook/Data DictionaryXLSX
Data Dictionary - Neutrophils Dataset
Neutrophils Dataset Data Dictionary used as a collection of metadata - defines the dataset's variable contentsCodebook/Data DictionaryXLSX
Data Dictionary - Patient Status Dataset
Patient Status Dataset Data Dictionary used as a collection of metadata - defines the dataset's variable contentsCodebook/Data DictionaryXLSX
Data Dictionary - Phosphorus Dataset
Phosphorus Dataset Data Dictionary used as a collection of metadata - defines the dataset's variable contentsCodebook/Data DictionaryXLSX
Data Dictionary - Pilots Primary Endpoint Dataset
Pilot Primary Endpoint Dataset Data Dictionary used as a collection of metadata - defines the dataset's variable contentsCodebook/Data DictionaryXLSX
Data Dictionary - Platelets Dataset
Platelet Dataset Data Dictionary used as a collection of metadata - defines the dataset's variable contentsCodebook/Data DictionaryXLSX
Data Dictionary - Potassium Dataset
Potassium Dataset Data Dictionary used as a collection of metadata - defines the dataset's variable contentsCodebook/Data DictionaryXLSX
Data Dictionary - PRA Dataset
PRA Dataset Data Dictionary used as a collection of metadata - defines the dataset's variable contentsCodebook/Data DictionaryXLSX
Data Dictionary - Primary and Key Secondary Endpoints Dataset
Primary and Key Secondary Endpoints Dataset Data Dictionary used as a collection of metadata - defines the dataset's variable contentsCodebook/Data DictionaryXLSX
Data Dictionary - PT Dataset
PT Dataset Data Dictionary used as a collection of metadata - defines the dataset's variable contentsCodebook/Data DictionaryXLSX
Data Dictionary - PTT Dataset
PTT Dataset Data Dictionary used as a collection of metadata - defines the dataset's variable contentsCodebook/Data DictionaryXLSX
Data Dictionary - Pulse Dataset
Pulse Dataset Data Dictionary used as a collection of metadata - defines the dataset's variable contentsCodebook/Data DictionaryXLSX
Data Dictionary - Retinopathy Dataset
Retinopathy Dataset Data Dictionary used as a collection of metadata - defines the dataset's variable contentsCodebook/Data DictionaryXLSX
Data Dictionary - RudBeckClinical Dataset
Rud Beck Clinical Dataset Data Dictionary used as a collection of metadata - defines the dataset's variable contentsCodebook/Data DictionaryXLSX
Data Dictionary - Safety Dataset
Safety Dataset Data Dictionary used as a collection of metadata - defines the dataset's variable contentsCodebook/Data DictionaryXLSX
Data Dictionary - Serology Dataset
Serology Dataset Data Dictionary used as a collection of metadata - defines the dataset's variable contentsCodebook/Data DictionaryXLSX
Data Dictionary - SF36 Dataset
SF36 Dataset Data Dictionary used as a collection of metadata - defines the dataset's variable contentsCodebook/Data DictionaryXLSX
Data Dictionary - Sodium Dataset
Sodium Dataset Data Dictionary used as a collection of metadata - defines the dataset's variable contentsCodebook/Data DictionaryXLSX
Data Dictionary - Systolic Blood Pressure Dataset
Systolic Blood Pressure Dataset Data Dictionary used as a collection of metadata - defines the dataset's variable contentsCodebook/Data DictionaryXLSX
Data Dictionary - Trough Level Dataset
Trough Level Dataset Data Dictionary used as a collection of metadata - defines the dataset's variable contentsCodebook/Data DictionaryXLSX
Data Dictionary - TSH Dataset
TSH Dataset Data Dictionary used as a collection of metadata - defines the dataset's variable contentsCodebook/Data DictionaryXLSX
Data Dictionary - WBC Dataset
WBC Dataset Data Dictionary used as a collection of metadata - defines the dataset's variable contentsCodebook/Data DictionaryXLSX
Data Dictionary - Weight Dataset
Weight Dataset Data Dictionary used as a collection of metadata - defines the dataset's variable contentsCodebook/Data DictionaryXLSX
CIT-03 Data Dictionary
Data Dictionary used as a collection of metadata - defines the variable contents of each datasetCodebook/Data DictionaryXLS
If you need accessible versions of documents, please email your request to NIDDK-CRsupport@niddk.nih.gov

Permitted Use(s) of the Resources
  • Use is allowed for any research purpose
Non-Public Documents (0)
There are currently no non-public documents available
Datasets (77)
Datasets Table
Dataset Name
Description
# of Records
# of Variables
File Format(s)
Clarke Dataset
Captures data related to low blood sugar status and symptoms, including confusion, seizures, unconsciousness, and requiring intravenous glucose or glucagon 87txt (4.43 KB); csv (4.43 KB)
Variable Names
  • Accession
  • StudyID
  • NumDaysInitial
  • flag08
  • pstintvst
  • pstfinvst
  • Category
  • category2
  • Symptoms
  • symptoms2
  • HypoConfused
  • HypoConfused2
  • HypoUnconsious
  • HypoUnconsious2
  • ReadingSymptoms
  • ReadingWithoutSymptoms
  • ReadingWithoutSymptoms2
  • LowBloodSugar
  • LowBloodSugar2
  • ExtentLowBloodSugar
  • ExtentLowBloodSugar2
  • clarke_score
Pilot Endpoints Dataset
Captures data on primary endpoint criteria, information, and results15txt (693 B); csv (693 B)
Magnesium Dataset
Captures data on magnesium laboratory value, unit, and time point indicator based on initial and final transplant581txt (13.62 KB); csv (13.62 KB)
Diastolic Blood Pressure
Captures diastolic blood pressure, number of days from initial transplant, and time point indicator based on initial and final transplant443txt (9.96 KB); csv (9.96 KB)
BUN Dataset
Captures BUN test results and number of days from initial transplant597txt (13.42 KB); csv (13.42 KB)
Albumin Dataset
Captures albumin test results, units, and number of days from initial transplant593txt (13.84 KB); csv (13.84 KB)
Sodium Dataset
Captures sodium laboratory value and time point indicator based on initial and final transplant597txt (14.07 KB); csv (14.07 KB)
Local LDL Dataset
Captures data on local LDL laboratory value, unit, and time point indicator based on initial and final transplant245txt (6.01 KB); csv (6.01 KB)
EQ5D Dataset
Captures data from the EQ5D, including mobility, anxiety/depression, usual activities, pain/discomfort, health state, self-care, and overall index118txt (4.68 KB); csv (4.68 KB)
Local Total Cholesterol Dataset
Captures data on local total cholesterol laboratory value and time point indicator based on initial and final transplant245txt (6.15 KB); csv (6.15 KB)
Lability Index (LI) Score Dataset
Captures Lability Index (LI) Score and time point indicator based on initial and final transplant41txt (967 B); csv (967 B)
Hematocrit Dataset
Captures data on hematocrit laboratory value, unit, and time point indicator based on initial and final transplant598txt (14.54 KB); csv (14.54 KB)
Potassium Dataset
Captures potassium laboratory value, unit, and time point indicator based on initial and final transplant597txt (13.96 KB); csv (13.96 KB)
General Assessment Dataset
Captures general assessment data, including tuberculosis results, ECG interpretation, stress test interpretation, X-ray results, urinalysis results, abdominal ultrasound interpretation, and myocardial scintigram interpretation96txt (4.73 KB); csv (4.73 KB)
Patient Status Dataset
Captures patient status data, including number of transplants and number of days since first transplant14txt (316 B); csv (316 B)
Endpoints Dataset
Captures endpoints data, including insulin independence and requirements such as reduction from baseline in HbA1c, capillary glucose count, maximum insulin, subject titrated off insulin, subject met fasting serum glucose criteria, subject met post-prandial criteria, etc.84txt (5.26 KB); csv (4.91 KB)
TSH Dataset
Captures TSH (mIU/L) laboratory value and time point indicator based on initial and final transplant23txt (591 B); csv (591 B)
Systolic Blood Pressure Dataset
Captures systolic blood pressure (mm HG) and time point indicator based on initial and final transplant443txt (10.38 KB); csv (10.38 KB)
Manufacturing Dataset
Captures data on cobe process, if donor received high dose inotropic support, cross clamp, peak dose, glucose peak and low, creatinine peak and low, sodium peak and low, ALT peak and low, insulin administration, cardiac arrest duration, if donor was hemodiluted, total volume of blood, colloid, and crystalloid transfused, test blood sample, if donor is suitable, pulmozyme, collagenase lot number, enzymatic time, packed tissue volume, disposition, fungal cultures, etc. 23txt (27.94 KB); csv (27.94 KB)
Blood Type HLA Dataset
Captures data on blood type and HLA20txt (863 B); csv (863 B)
Beta Score Dataset
Captures data on fasting glucose score, HbA1c score, insulin score, stimulated Cpeptide at 90 minutes score, beta score (sum of glucscore, hba1score, insulin score, and cpepscore) and time point indicator based on initial and final transplant82txt (2.13 KB); csv (2.13 KB)
AST Dataset
Captures AST test results, time point indicator based on initial and final transplant, and number of days from initial transplant593txt (13.54 KB); csv (13.54 KB)
Lymphocyte Dataset
Captures data on lymphocytes laboratory value and time point indicator based on initial and final transplant593txt (14.14 KB); csv (14.14 KB)
Neutrophils Dataset
Captures neutrophil laboratory value and time point indicator based on initial and final transplant593txt (14.1 KB); csv (14.1 KB)
Local HDL Dataset
Captures data on local HDL laboratory value, unit, and time point indicator based on initial and final transplant245txt (5.94 KB); csv (5.94 KB)
Blood Sugar Dataset
Captures blood sugar reading measurement (mg/DL), meal time indicator, autonomic, confusion, neurologic, seizure, and visual hypoglycemia symptoms, and treatment for reaction 37971txt (1.76 MB); csv (1.76 MB)
Islet Equivalent (IEQ) Infused Dataset
Captures data on islet equivalent (IEQ) infused results23txt (1.61 KB); csv (1.52 KB)
Trough Level Dataset
Captures data on drug name and trough level (ng/ML)1009txt (32.11 KB); csv (32.11 KB)
Atherogenic Dataset
Captures data on atherogenic information and results31txt (1.83 KB); csv (1.83 KB)
Albumin Creatinine GFR Components Dataset
Captures albumin-creatinine and GFR components test results, including urine creatinine, urine microalbumin, microalbumin/creatinine ratio, iohexol, body surface area, and coefficient of determination142txt (7.95 KB); csv (7.95 KB)
Alkaline Phosphatase Dataset
Captures alkaline phosphatase test results, units, and number of days from initial transplant593txt (13.53 KB); csv (13.53 KB)
Calcium Dataset
Captures data on calcium laboratory value, unit, and number of days from initial transplant593txt (13.84 KB); csv (13.84 KB)
Gamma GT Dataset
Captures Gamma GT value and time point indicator based on initial and final transplant571txt (13.01 KB); csv (13.01 KB)
Retinopathy Dataset
Captures retinopathy data, including retinopathy stage of each eye and time point indicator based on initial and final transplant21txt (600 B); csv (600 B)
CO2 Dataset
Captures data on CO2 laboratory value, unit, and number of days from initial transplant587txt (13.26 KB); csv (13.26 KB)
Safety Dataset
Captures data on safety and adverse events, including system organ class, severity, and relation to islet, immunosuppression, or drug625txt (46.59 KB); csv (46.65 KB)
Local Serum Creatinine Dataset
Captures data on local serum creatinine laboratory value, unit, and time point indicator based on initial and final transplant596txt (13.38 KB); csv (13.38 KB)
Local Triglycerides Dataset
Captures data on local triglycerides cholesterol laboratory value and time point indicator based on initial and final transplant245txt (5.96 KB); csv (5.96 KB)
Diabetes Distress Scale Dataset
Captures data related to diabetes distress, including emotional burden, regimen distress, interpersonal distress, and physician distress115txt (9.46 KB); csv (9.46 KB)
Hypoglycemic Score Dataset
Captures data on composite hypoglycemic score and time point indicator based on initial and final transplant40txt (814 B); csv (814 B)
Central HDL Dataset
Captures data on central HDL laboratory value, unit, and time point indicator based on initial and final transplant31txt (837 B); csv (837 B)
FSIGT AIRglu Dataset
Captures data on acute insulin response to glucose (AIRglu) derived from FSIGT and time point indicator based on initial and final transplant60txt (2.02 KB); csv (2.02 KB)
Hypoglycemic Recall Dataset
Captures recall data related to hypoglycemia, including number of hypoglycemic episodes in the past year the subject needed help to recognize, help to treat, or required an ambulance call62txt (1.74 KB); csv (1.74 KB)
Auto Antibodies Dataset
Captures data on positive baseline IAA, positive baseline GAD65, and positive baseline ICA512103txt (3.59 KB); csv (3.59 KB)
Mage Dataset
Captures data on mean amplitude of glycemic excursions (MAGE) (mg/dL) and time point indicator based on initial and final transplant57txt (1.21 KB); csv (1.21 KB)
Pulse Dataset
Captures pulse (beats/min) data and time point indicator based on initial and final transplant443txt (9.98 KB); csv (9.98 KB)
Serology Dataset
Captures serology data including viruses such as HIV, hepatitis C, Epstein-Barr, cytomegalovirus, etc.91txt (3.2 KB); csv (3.2 KB)
Central LDL Dataset
Captures data on central LDL laboratory value, unit, and time point indicator based on initial and final transplant31txt (845 B); csv (845 B)
Bilirubin Dataset
Captures data on bilirubin laboratory value, unit, and number of days from initial transplant593txt (13.92 KB); csv (13.92 KB)
Phosphorus Dataset
Captures phosphorus laboratory value and time point indicator based on initial and final transplant574txt (13.43 KB); csv (13.43 KB)
Insulin Dataset
Captures data on insulin use (units/day) and time point indicator based on initial and final transplant9877txt (225.49 KB); csv (225.49 KB)
CGMS Dataset
Captures data on glucose average sensor value, number of episodes, duration, etc.59txt (8.28 KB); csv (8.28 KB)
Chloride Dataset
Captures data on chloride laboratory value, unit, and number of days from initial transplant596txt (14.05 KB); csv (14.05 KB)
WHO Coding Dataset
Captures WHO coding information421txt (15.58 KB); csv (15.58 KB)
Manufacturing Other Dataset
Captures data on all other information and results associated with study manufacturing23txt (14.62 KB); csv (14.62 KB)
Hemoglobin Dataset
Captures data on hemoglobin laboratory value, unit, and time point indicator based on initial and final transplant598txt (14.66 KB); csv (14.66 KB)
PTT Dataset
Captures partial thromboplastin time (seconds) data and number of days from initial transplant61txt (1.26 KB); csv (1.26 KB)
CIMT Dataset
Captures data on Carotid Intima-Media Thickness (CIMT) diagnostic test results1txt (187 B); csv (187 B)
White Blood Count Dataset
Captures white blood count laboratory value and time point indicator based on initial and final transplant598txt (14.1 KB); csv (14.1 KB)
SF-36 Dataset
Captures patient-reported data on quality of life and well-being from the SF-36 Health Survey114txt (12.03 KB); csv (12.03 KB)
Cpeptide Glucose Creatinine Dataset
Captures data on graft function, fasting and stimulated Cpeptide, fasting and stimulated glucose, and creatinine ratio303txt (18.78 KB); csv (18.78 KB)
Central Total Cholesterol Dataset
Captures data on central total cholesterol laboratory value and time point indicator based on initial and final transplant31txt (865 B); csv (865 B)
FSIGT Raw Dataset
Captures data on glucose (mg/dL), insulin (Tosoh) (uU/mL), and time point indicator based on initial and final transplant1426txt (45.64 KB); csv (45.64 KB)
Drug Dose Dataset
Captures data on drug dose and administration1155txt (43.24 KB); csv (45.42 KB)
HbA1c Dataset
Captures data on HbA1c derived from the Washington lab and time point indicator based on initial and final transplant206txt (5.04 KB); csv (5.04 KB)
Hypoglycemia Fear Survey Dataset
Captures data from the Hypoglycemia Fear Survey, which measures feelings of worries and fears related to hypoglycemia114txt (10.91 KB); csv (10.91 KB)
Platelets Dataset
Captures platelets laboratory value and time point indicator based on initial and final transplant598txt (14.19 KB); csv (14.19 KB)
Rudbeck Clinical Dataset
Captures data on Cpeptide (pmol/L), C3a (ug/L), and TAT III complex (ug/L)100txt (3.65 KB); csv (3.65 KB)
Mean Insulin Dataset
Captures mean insulin (units/day) over a 7 consecutive day interval (7 closest days prior to transplant for baseline), weight, and time point indicator based on initial and final transplant78txt (3.35 KB); csv (3.35 KB)
PRA Dataset
Captures data on percent calculated PRA and number of days from initial transplant168txt (3.17 KB); csv (3.17 KB)
ALT Dataset
Captures ALT test results, time point indicator based on initial and final transplant, and number of days from initial transplant594txt (13.55 KB); csv (13.55 KB)
PT Dataset
Captures prothrombin time (seconds) data and number of days from initial transplant55txt (1.17 KB); csv (1.17 KB)
Glomerular Filtration Rate Dataset
Captures glomerular filtration rate, unit, and time point indicator based on initial and final transplant95txt (2.51 KB); csv (2.51 KB)
Demographics Dataset
Captures demographic data including gender, age at first transplant, race; also captures data on duration of diabetes, weight, and BMI14txt (645 B); csv (645 B)
Medical History Dataset
Captures medical history data including allergies, hospitalizations, and any conditions14txt (823 B); csv (823 B)
Weight Dataset
Captures weight (kg) data and time point indicator based on initial and final transplant398txt (9.71 KB); csv (9.71 KB)
Central Triglycerides Dataset
Captures data on central triglycerides cholesterol laboratory value and time point indicator based on initial and final transplant31txt (846 B); csv (846 B)
Specimens (1,172)
Specimens Table
Specimen
Count
Islet Cells4
PB-PBMC387
Plasma362
RNA233
Serum186